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A Phase III Trial of With Marizomib in Patients With Newly Diagnosed Glioblastoma

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ClinicalTrials.gov Identifier: NCT03345095
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : June 17, 2019
Sponsor:
Collaborators:
Celgene
Canadian Cancer Trials Group
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Tracking Information
First Submitted Date  ICMJE November 7, 2017
First Posted Date  ICMJE November 17, 2017
Last Update Posted Date June 17, 2019
Actual Study Start Date  ICMJE July 26, 2018
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2017)
Overall Survival (OS) [ Time Frame: From the date of randomization up to the date of death, assessed up to 49 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03345095 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2017)
  • Progression Free Survival (PFS) [ Time Frame: From the date of randomization until the date of first objective progression or the date of patient's death whichever occurs first, assessed up to 49 months ]
  • Health-related Quality of life (HRQol) [ Time Frame: From randomization until progression, assessed up to 49 months ]
    HRQoL will be assessed with the EORTC Quality of Life Questionnaire (QLQ-C30) version 3.
  • Mini Mental State Examination (MMSE) [ Time Frame: From the date of randomization until end of treatment, assessed up to 49 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase III Trial of With Marizomib in Patients With Newly Diagnosed Glioblastoma
Official Title  ICMJE A Phase III Trial of Marizomib in Combination With Standard Temozolomide-based Radiochemotherapy Versus Standard Temozolomide-based Radiochemotherapy Alone in Patients With Newly Diagnosed Glioblastoma
Brief Summary The standard of care for newly diagnosed glioblastoma includes surgery, involved-field radiotherapy, and concomitant and six cycles of maintenance temozolomide chemotherapy, however the prognosis remains dismal. Marizomib has been tested in patients with newly diagnosed and recurrent glioblastoma in phase I and phase II studies. In patients with recurrent glioblastoma, marizomib was administered as a single agent or in combination with bevacizumab (NCT02330562). Based on encouraging observations, a phase I/II trial of marizomib in combination with TMZ/RT -->TMZ in newly diagnosed glioblastoma has been launched (NCT02903069) which explores safety and tolerability of this triple combination and which shall help to determine the dose for further clinical trials in glioblastoma. In this context, given that marizomib has been established as a safe addition to the standard TMZ/RT -->TMZ, a phase III study is considered essential to establishing its impact on overall survival.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Newly Diagnosed Glioblastoma
Intervention  ICMJE
  • Drug: Marizomib
    Intravenous administration of Marizomib
    Other Name: MRZ
  • Drug: Temozolomide
    Oral Administration of Temozolomide
    Other Name: TMZ
  • Radiation: radiotherapy
    60 Gy in 30 fractions over 6 weeks
    Other Name: RT
Study Arms  ICMJE
  • Experimental: Experimental Arm
    Radiotherapy + Temozolomide + Marizomib followed by adjuvant Temozolomide + Marizomib
    Interventions:
    • Drug: Marizomib
    • Drug: Temozolomide
    • Radiation: radiotherapy
  • Active Comparator: Standard Arm
    Radiotherapy + Temozolomide followed by adjuvant Temozolomide
    Interventions:
    • Drug: Temozolomide
    • Radiation: radiotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 14, 2017)
750
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2023
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed newly diagnosed glioblastoma (WHO grade IV)
  • Tumor resection (gross total or partial), or biopsy only
  • Availability of FFPE tumor block or 24 unstained slides for MGMT analysis
  • Patient must be eligible for standard TMZ/RT + TMZ
  • Karnofsky performance score (KPS) ≥ 70
  • Recovered from effects of surgery, postoperative infection and other complications of surgery (if any)
  • The patient is at least 18 years of age on day of signing informed consent
  • Stable or decreasing dose of steroids for at least 1 week prior to inclusion
  • The patient has a life expectancy of at least 3 months
  • Patient has undergone a brain MRI within 14 days of randomization but after intervention (resection or biopsy)
  • The patient shows adequate organ functions as assessed by the specified laboratory values within 2 weeks prior to randomization defined as adequate bone marrow, renal and hepatic function within the following ranges:

    • WBC ≥ 3×10*9/L
    • ANC ≥ 1.5×10*9/L
    • Platelet count of ≥ 100×10*9/L independent of transfusion
    • Hemoglobin ≥ 10 g/dl
    • Total Bilirubin ≤ 1.5 ULN
    • ALT, AST, alkaline phosphatase (ALP) ≤ 2.5 × ULN
    • Serum creatinine < 1.5 x ULN or creatinine clearance (CrCl) > 30 mL/min(using the Cockcroft-Gault formula)
  • Women of child bearing potential (WOCBP) must have a negative urine or serum pregnancy test within 7 days prior to the first dose of study treatment.
  • Patients of childbearing / reproductive potential must agree to use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least 6 months after the last study treatment. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1 percent per year) when used consistently and correctly. Patients must also agree not to donate sperm during the study and for 6 months after receiving the last dose of study treatment.
  • Women who are breast feeding must agree to discontinue nursing prior to the first dose of study treatment and until 6 months after the last study treatment.
  • Ability to take oral medication
  • Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and return for the required assessments.
  • Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: EORTC +3227741611 eortc@eortc.org
Listed Location Countries  ICMJE Austria,   Belgium,   Canada,   Denmark,   France,   Germany,   Netherlands,   Norway,   Spain,   Switzerland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03345095
Other Study ID Numbers  ICMJE EORTC-BTG-1709
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party European Organisation for Research and Treatment of Cancer - EORTC
Study Sponsor  ICMJE European Organisation for Research and Treatment of Cancer - EORTC
Collaborators  ICMJE
  • Celgene
  • Canadian Cancer Trials Group
Investigators  ICMJE
Principal Investigator: Patrick Roth EORTC Study Coordinator
PRS Account European Organisation for Research and Treatment of Cancer - EORTC
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP